Sensor, Glucose, Invasive
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- IPRO2 CGM SYSTEM WITH ENLITE SENSOR
- PMA Number
- P150029
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 17, 2016
- Date Received
- August 10, 2015
- Expedited Review
- N
- Docket Number
- 16m-1755
Advisory Committee Statement
Approval for the iPro2 System. This device is indicated for:The iPro2 Recorder is to be used with either Enlite sensor or Sof-Sensor and is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring device. The information collected by the iPro2 Recorder may be uploaded to a computer (with Internet access) and reviewed by healthcare professionals. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.The iPro2 system:1) Is intended for prescription use only;2) Does not allow data to be made available directly to patients in real time;3) Provides data that will be available for review by physicians after the recording interval (up to 144 hours);4) Is intended for occasional rather than everyday use; and5) Is to be used only as a supplement, and not a replacement for, standard invasive measurement.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDS | Sensor, Glucose, Invasive | FDA class 3 | Unknown |